Heart Failure Clinical Trial
HF2 Registry – Hemodynamic Frontiers in Heart Failure Registry
Summary
The purpose of the HF2 (Hemodynamic Frontiers in Heart Failure) registry is to collect relevant patient-level demographic, clinical, laboratory, and hemodynamic data from patients implanted with pulmonary artery pressure sensor at participating centers to advance scientific knowledge about ambulatory hemodynamics monitoring and HF (Heart Failure) therapies. The data collected will be used for retrospective studies, quality improvement, identifying research cohorts, and member-initiated research.
Full Description
Longitudinal, multi-center, and non-interventional registry. Patients will be identified as eligible for pulmonary artery pressure sensor implant by a heart failure cardiologist from the heart failure clinic. They will consent for device implant and procedure (right heart catheterization) per standard of care. Patients may also consent to the registry participation, which is optional. They will be informed that the registry intends to gather data and that they may be approached in the future for additional research based on their data and clinical situation. Additionally, patients who underwent pulmonary artery pressure sensor implantation from January 1, 2019, will be identified and consent will be obtained for registry participation, which is optional.
Eligibility Criteria
Inclusion Criteria:
All patients would have been or will be implanted per indications from FDA approval/CHAMPION trial. These would be patients with NYHA (New York Heart Association) Class III heart failure who had a prior hospitalization.
Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II).
Exclusion Criteria:
Patients less than 18 years of age.
Pregnant women at the scheduled time of PA pressure sensor implant.
Patients unable or unwilling to have continuity of care in the heart failure clinic.
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There are 12 Locations for this study
La Jolla California, 92037, United States More Info
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Principal Investigator
Bloomington Indiana, 47401, United States More Info
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Principal Investigator
Kansas City Kansas, 66160, United States More Info
Principal Investigator
Maplewood Minnesota, 55109, United States More Info
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Principal Investigator
Minneapolis Minnesota, 55407, United States More Info
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Principal Investigator
Kansas City Missouri, 64131, United States More Info
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Principal Investigator
Raleigh North Carolina, 27607, United States More Info
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Principal Investigator
Portland Oregon, 97225, United States More Info
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Principal Investigator
Columbia South Carolina, 29203, United States More Info
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Principal Investigator
Sioux Falls South Dakota, 57104, United States More Info
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Principal Investigator
Austin Texas, 78756, United States More Info
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Principal Investigator
Houston Texas, 77030, United States More Info
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Principal Investigator
Principal Investigator
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